Prospective Study on Cesarean Wound Outcomes

Post Operative Pain Clinical Trial

Official title:

A Prospective Randomized Study Assessing Post Operative Wound Infections Along With Cosmetic Outcomes Using Silver Impregnated Dressings Compared to Conventional Dressings on Cesarean Section Incisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697748
• Other study ID #: USF IRB 00008650
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: May 2018

Study information

• Verified date: December 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate whether the placement of silver impregnated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver impregnated dressings are used compared to the Telfa pads.

The study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.

Description:

This is a randomized, prospective study involving 660 patients undergoing cesarean sections at Tampa General Hospital. The control group (n=330) will receive standard Telfa pad dressing and the treatment group (n=330) will receive the silver impregnated dressing.

The primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at the 1-week and 6-weeks post operative visits. The secondary objective is to assess the cosmetic outcome of the cesarean incision observed at the 1-week and 6-week post-operative visits. A plastic surgery investigator will also conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks.The tertiary objective is to evaluate the amount of narcotic and non narcotic medicine consumed during the hospitalization and query the patient with regards to pain involving the cesarean wound at 1 and 6 week post-operative visits

Other known NCT identifiers

• NCT01927211

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: May 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Elective and emergent cesarean deliveries

• Primary and repeat cesarean sections

• Transverse skin incisions (Pfannenstiel)

• Low transverse uterine incisions

• Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment prior to or after the delivery of the baby

• Single and multiple gestations

• Able and willing to provide written informed consent

Exclusion Criteria:

• Patients that did not receive routine prophylactic dose of antibiotics in the operating room.

• Skin incisions other than Pfannenstiel

• Uterine incisions other than low transverse

• Patients with known or discovered allergy to silver or nylon

Related Conditions & MeSH terms

• Cosmetic Appearance of Cesarean Scar
• Infection
• Pain, Postoperative
• Post Operative Pain
• Surgical Site Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• Silver-impregnated dressing
Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
• Telfa pad dressing
Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.

Locations

Country	Name	City	State
United States	USF Health Morsani Center for Advanced Healthcare	Tampa	Florida
United States	USF Health South Tampa Center for Advanced Healthcare	Tampa	Florida
United States	Women's Center Operating Rooms at the Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (12)

Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24. — View Citation

Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. — View Citation

Epstein NE. Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? Surg Neurol. 2007 Nov;68(5):483-5; discussion 485. — View Citation

Huckfeldt R, Redmond C, Mikkelson D, Finley PJ, Lowe C, Robertson J. A clinical trial to investigate the effect of silver nylon dressings on mediastinitis rates in postoperative cardiac sternotomy incisions. Ostomy Wound Manage. 2008 Oct;54(10):36-41. — View Citation

Leaper DJ. Silver dressings: their role in wound management. Int Wound J. 2006 Dec;3(4):282-94. Review. — View Citation

Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Téot L, Wood FM, Ziegler UE; International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002 Aug;110(2):560-71. Review. — View Citation

Olsen MA, Butler AM, Willers DM, Devkota P, Gross GA, Fraser VJ. Risk factors for surgical site infection after low transverse cesarean section. Infect Control Hosp Epidemiol. 2008 Jun;29(6):477-84; discussion 485-6. doi: 10.1086/587810. — View Citation

Opøien HK, Valbø A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. — View Citation

Owens SM, Brozanski BS, Meyn LA, Wiesenfeld HC. Antimicrobial prophylaxis for cesarean delivery before skin incision. Obstet Gynecol. 2009 Sep;114(3):573-9. doi: 10.1097/AOG.0b013e3181b490f1. — View Citation

Perkins James, Pattillo Rolandid. How to Avert Postoperative Wound Complications-Treat It when It Occurs. OBG Management 2009;21(10):43-53.

Thomas Steve. MRSA and the Use of Silver Dressings: Overcoming Bacterial Resistance. http://www.worldwidewounds.com/2004/november/Thomas/Introducing-Silver Dressings.html.

Yiannias, James. Clinical features and diagnosis of allergic contact dermatitis. http://www.uptodate.com/contents/clinical-features-and-diagnosis-of-allergic-contact-dermatitis

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction of Pain After Cesarean Delivery	The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded	Immediately post operatively to hospital discharge
Other	The Number of Participants Noting Pain at the One Week Post Cesarean Visit	Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.	Post operative day 7
Other	The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit	Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.	6 weeks post operative
Primary	Percentage of Patients Who Develop a Surgical Site Infection	A surgical site infection involving the skin and subcutaneous tissue is defined as either; The presence of a purulent discharge from the wound on inspection, or; Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or; The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.	from post operative day #1 through post operative day 30
Secondary	Cosmetic Outcome of the Cesarean Section Incision	The following instruments will be used to determine the cosmetic outcome: • The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)	Post operative day 7
Secondary	Cosmetic Outcome of the Cesarean Section Incision	The following instruments will be used to determine the cosmetic outcome; • The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)	Six weeks post-operative